Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.5 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.5 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.15 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.15 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
100 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
81 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
8.1 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
16 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.24 mg/kg food
Assessment factor:
3 000

Additional information

No hazard to the environment has been determined for the registered substance in any acute or chronic ecotoxicological study available to date. Long-term results on fish are still outstanding, but according to the pre-experiments performed so far, no effects are expected and the definitive test will be running as an extended limit test. Due to the fast hydrolysis (DT50 = 37s, Neuland 2020) and the poor water solubility, which could not be determined experimentally thereby, the preparation of test solutions with TRIDI was very difficult. As recommended in the OECD Guidance Document No. 23 on aqueous phase aquatic toxicity testing of difficult test chemicals (second edition, February 2019) solubility pre-experiments including analytical dose verification were performed before initiation of any aquatic toxicity testing to determine the maximum dissolved concentration that can be achieved in the specific test solution under test conditions. In the long-term studies, the maintenance and reproducibility of test medium concentrations could only be achieved by the use of the solvent DMF, which limited the concentration of the test solutions. It can therefore be concluded that no effects have been determined up to the "water solubility" of the test substance or rather the highest possible concentration of the test substance in water. Hence, it is expected that the test substance poses no hazard to the environment based on the available data.

Due to the fact that one chronic test (to fish) is still outstanding, PNEC deviation and Environmental Risk Assessment have been conducted for completion using a worst case assumption so far. If the results of the pending fish study confirm that there is no risk to the environment, the Environmental Risk Assessment will be regarded unnecessary.

Conclusion on classification

Considering all available data on short- and long-term toxicity to aquatic organisms, no acute toxicity was determined for the aquatic environment. However, based on the available long-term results (NOEC 0.1 mg/L), the test substance will be classified as Aquatic Chronic Category 1 according toRegulation (EC) No 1272/2008 as worst case assumption.